cliffwatch

lidocaine · Scilex Pharms · NDA 207962

Ztlido

Earliest generic entry, as listed
10 May 2031

Blocked by patent: US 10765640, US 10765749, US 11278623, US 11786455, US 11793766, US 9283174, US 9925264, US 9931403.

FDA has approved 2 generic applications (ANDAs) for Ztlido, though its earliest generic-entry date is 10 May 2031 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 8 unexpired

PatentClaimsExpires
US 10765640product10 May 2031
US 10765749product10 May 2031
US 11278623product10 May 2031
US 11786455product, use U-226710 May 2031
US 11793766use U-226710 May 2031
US 9283174product10 May 2031
US 9925264product, use U-226710 May 2031
US 9931403product10 May 2031

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • 25 Oct 2026Generic approved · 207962-001
  • 25 Oct 2026Generic approved · 207962-001

Products covered · 1

NDA · productFormStrengthListed expiry
207962 · 001 · RLDpatch, topical1.8%10 May 2031